Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy

Phase 3

• Conditions: Colonic Diseases
• Interventions: Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT03466632
• Lead Sponsor: Tanta University

Brief Summary

Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Detailed Description

Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Study Timeline

• Study Start: 2016-04-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Study First Posted: 2018-03-15
• Last Update Posted: 2018-03-15
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• aged 25-45 years,
• ASA class I or II,
• who are scheduled for elective outpatient colonoscopy

Exclusion Criteria

• refused to give informed consent
• if they had known hypersensitivity to the used drugs
• patients with morbidly obese patients
• patients with increased risk for airway obstruction as obstructive sleep apnea,
• Liver diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
• Dexmedetomidine Group	Dexmedetomidine	dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure
• Propofol Group	Propofol	propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure..

Primary Outcome Measures

Name	Time	Method
Number of patients with adequate sedation	6 months	the number of patients adequately sedated

Trial Locations

Locations (1)

Sameh Abdelkhalek Ahmed; 🇪🇬 Zagazig, Egypt